Type-2 DiabetesVASNCT04105608
GLP-1 and Oxyntomodulin Release in Relation to Diet in Type 2 Diabetes Patients.
A study testing High-fiber vegetarian meal and Mediterranean-like meal in people with Type-2 Diabetes, run by Antonio Di Mauro at 1 site in Italy.
Trial summary
The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type-2 Diabetes
- What is being tested?
- High-fiber vegetarian meal and Mediterranean-like meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2017to 28 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.
Who cannot join
- clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mediterranean-pattern Meal Increases GLP-1 and Oxyntomodulin More Than an Energy-matched High Fiber Plant-Based Meal in Type 2 Diabetes Patients: A Randomized Clinical Trial Assessment Through the Visual Analogue Scale.
The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.
Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.
Read the detailed description
Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.
The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.
Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.
- Conditions
- Type-2 Diabetes
- Being tested
- High-fiber vegetarian meal, Mediterranean-like meal
- Keywords
- Diabetes, GLP-1, Oxyntomodulin, Diet, Visual Analogue Scale
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-fiber vegetarian mealDietary supplement
The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.
Mediterranean-like mealDietary supplement
Also called Control meal
The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.
| Study group | Role | What they receive |
|---|---|---|
| HFV meal | Experimental | A vegetarian meal high in dietary carbohydrate and fiber Receives: Dietary Supplement: High-fiber vegetarian meal |
| MED meal | Active comparator | A Mediterranean-like meal Receives: Dietary Supplement: Mediterranean-like meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in serum GLP-1 concentration
Changes in serum GLP-1 levels following the ingestion of the two meals
Measured: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Secondary outcomes (3)
Changes in plasma oxyntomodulin concentration
Plasma oxyntomodulin assessment in relation to HFV and MED meal.
Measured: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Serum glucose and insulin levels
Serum blood glucose and insulin levels
Measured: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Hunger-satiety scores (millimeters)
We assessed VAS scores in relation to meals through the quantification of self-reported hunger, satiety, and desire to eat. Participants were asked to mark a validated 10-mm horizontal scale (Visual analogue scale) at multiple time points [0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)]. These ratings were subsequently quantified and assessed for potential correlation with any of the hormones assessed (i.e., GLP-1, oxyntomodulin, glucose, and insulin). Each scale had a left end equal to zero mm (i.e., "not at all") and a right end equal to 100 mm (i.e., "absolutely" or "definitely yes"), with no subscales. Each participant was instructed on how to fill the questionnaire properly and every assessment occurred with no disturbance and/or any other patient.
Measured: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Nov 2017
- Primary completion1 Dec 2017
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type-2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antonio Di Mauro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Antonio Di Mauro, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105608
- Sponsor's protocol ID
- 08/2017
- Acronym
- VAS
- Status last verified
- Sep 2019
- First submitted
- 23 Sep 2019
- Last updated
- 26 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Di Mauro A, Tuccinardi D, Watanabe M, Del Toro R, Monte L, Giorgino R, Rampa L, Rossini G, Kyanvash S, Soare A, Rosati M, Piccoli A, Napoli N, Fioriti E, Pozzilli P, Khazrai YM, Manfrini S. The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial. Diabetes Metab Res Rev. 2021 Sep;37(6):e3406. doi: 10.1002/dmrr.3406. Epub 2020 Sep 24.
PubMed 32926502
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mediterranean-pattern Meal Increases GLP-1 and Oxyntomodulin More Than an Energy-matched High Fiber Plant-Based Meal in Type 2 Diabetes Patients: A Randomized Clinical Trial Assessment Through the Visual Analogue Scale.
- ClinicalTrials.gov ID
- NCT04105608
- Acronym / sponsor ID
- VAS / 08/2017
- Conditions
- Type-2 Diabetes
- Keywords
- Diabetes, GLP-1, Oxyntomodulin, Diet, Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Antonio Di MauroUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial was to assess glycemic control and incretin release in subjects affected by type-2 diabetes, a condition in which GLP-1 release is impaired. It is known that nutrition affects a variety of factors in overall quality of life in diabetes and we hypothesized incretin secretion may improve in acute. As little is known regarding oxyntomodulin secretion in relation to diet, we explored this gut-derived hormone behavior as well.
Hence, the administration of two meals was carried out; these were equal in terms of calories but different for macronutrients composition. Appetite rating was assessed as well through a 100-mm horizontal Visual Analogue Scale, either at fasting and for 4 hours once the meal was completed.
Detailed description
Type-2 diabetes (T2D) is a multifactorial metabolic burden whose metabolic features include alterations in GLP-1 secretion and ultimately hunger/satiety circuit derangement. Manipulating the composition of the diet in order to promote GLP-1 secretion may represent a promising lifestyle strategy for obesity and T2D management.
The objective of this study was to assess the post-prandial profile of appetite- regulating hormones and assessing the post-prandial appetite ratings using a Visual Analogue Scale (VAS), as well as measuring the fasting and postprandial glucose/insulin responses in overweight and/or obese, well controlled patients with T2D.
Twelve T2D patients (M:F = 7:5) aged 63.1±8.5 years were enrolled in a randomized, controlled, crossover trial. Subjects consumed on two different days, at one-week interval, an experimental High Fiber Vegetarian meal (HFV) rich in dietary carbohydrate and fiber in comparison with a standard, Mediterranean-like meal (MED). The two meals were isocaloric. Appetite ratings, glucose/insulin and gastrointestinal hormone responses were assessed either at fasting and every 30' until 210' for GLP-1 and Oxyntomodulin and 240' for glucose and insulin after the ingestion of the meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFV meal | Experimental | Dietary Supplement: High-fiber vegetarian mealA vegetarian meal high in dietary carbohydrate and fiber |
| MED meal | Active comparator | Dietary Supplement: Mediterranean-like mealA Mediterranean-like meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type-2 diabetes history of at least 2 years, age above 18 years, body mass index (BMI) between 25 and 35 kg/m2, and drug naïve and/or with metformin treatment.
Key exclusion criteria (1 listed)
- clinically significant neurological, endocrinological, or other systemic diseases, as well as those with acute illness and chronic inflammatory or infective disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-fiber vegetarian mealThe intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff. | Dietary supplement | HFV meal |
| Mediterranean-like mealAlso: Control mealThe intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff. | Dietary supplement | MED meal |
Primary outcome
Changes in serum GLP-1 concentration
Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Changes in serum GLP-1 levels following the ingestion of the two meals
3 secondary outcomes
Changes in plasma oxyntomodulin concentration
Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Serum glucose and insulin levels
Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Hunger-satiety scores (millimeters)
Time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2019.
- Derived from this study: PubMed 32926502Di Mauro A, Tuccinardi D, Watanabe M, Del Toro R, Monte L, Giorgino R, Rampa L, Rossini G, Kyanvash S, Soare A, Rosati M, Piccoli A, Napoli N, Fioriti E, Pozzilli P, Khazrai YM, Manfrini S. The Mediterranean diet increases glucagon-like peptide 1 and oxyntomodulin compared with a vegetarian diet in patients with type 2 diabetes: A randomized controlled cross-over trial. Diabetes Metab Res Rev. 2021 Sep;37(6):e3406. doi: 10.1002/dmrr.3406. Epub 2020 Sep 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-fiber vegetarian meal and Mediterranean-like meal in people with Type-2 Diabetes, run by Antonio Di Mauro at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in serum GLP-1 concentration (time frame: 0' (fasting), +30', +60', +90', +120', +150', +180, +210', +240' (minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2019.